"This whole issue of rejection of a hypothesis, yes-no answers," she explained, "was created for agricultural and industrial studies, whether or not a certain widget would be produced more efficiently in one production method than another or whether one field is more productive than another in an agricultural setting, these are easy yes-no answers and don't impact human health."
A single-minded focus on significance testing is dangerous from a public health perspective, she said, because "it leads to discarding very important and relevant data and studies."
Glaxo's Own Meta-Analysis
While testifying, Kramer explained that a "meta-analysis is an analysis of all the data that have been generated on a subject, so it's an agglomeration, a statistical analysis of all the data to come up with a summary risk for all of the studies together."
"It's an attempt to overcome the issue of small sample sizes," she said, "so the individual doing the meta-analysis will take all of the studies and will actually combine all of the results into summary statistics so that there is more power and there is some attempt to come up with a summary of all of the data that have been generated to date."
The famous neuropsychopharmacology expert from Wales, Dr David Healy, also testified for the plaintiffs. During his testimony, the jury was presented with two charts from Glaxo's own website, showing the results of its own internal meta-analysis of the existing epidemiological studies.
The analysis had only been put on the website recently, he noted, maybe last year. One chart showed all birth defects lumped together, or combined, and the other showed cardiac birth defects.
In discussing the chart on combined birth defects, Healy said, "what everybody here needs to see is ... the little dots in the middle of the lines."
If you "look at the pattern of dots there, you will see that of all the studies that have now been done, most of the dots fall on the right-hand side," he noted. "This means that there is an increased risk that Paxil causes birth defects."
"What I want you to look at here ... is the consistency," he told the jury. "The dots are all falling on the right-hand side of the line, which shows an increased risk."
"When GlaxoSmithKline added all this up," Healy said, "you see the dot at the bottom, that is statistically significant."
"They say there is no chance that Paxil is not causing these birth defects. Chance is gone. It is causing the birth defects," he told the jury.
With the chart on cardiac birth defects, "again, you see the patterns of dots are mostly on the right," Healy pointed out.
"What you see here at the end," he said, "shows you a 1.5-fold increase in risk."
This "comes from their Web site," he stated, "I have had no part in trying to generate these data at all."
While testifying, Healy discussed several of the studies in Glaxo's analysis, including the abstract for a presentation given at a conference in 2001, referred to as Unfred, which also had an author named Chambers. The full paper on the study, with Chambers as the author, had never been published but the data was in Glaxo's database.
